[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655202":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":69,"studyPopulation":65,"armGroups":70,"interventions":77,"overallOfficials":65,"centralContacts":82,"locations":88,"responsibleParty":103,"collaborators":65,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":65,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":65,"studyType":118,"phases":119,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":91,"whyStopped":65,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Beijing Sungen Biomedical Technology Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":27,"otherOutcomes":42},[9,13,17,20,23],{"measure":10,"description":11,"timeFrame":12},"Adverse Events (AEs), immune-related Adverse Events (irAEs)","This includes clinically significant changes in vital signs, physical examination, electrocardiogram, echocardiogram and clinical laboratory tests, as graded by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 6.0.","First dose up to 28 days (+3 days) after EOT, or prior to initiation of other anti-tumor therapy, whichever occurs first.",{"measure":14,"description":15,"timeFrame":16},"Phase I: Dose Limit Toxicity (DLTs)","Evaluated at each dose level of SGT003 graded by NCI CTCAE v6.0.","Within the first dose cycle (Day1-Day21) of SGT003",{"measure":18,"description":19,"timeFrame":16},"Phase I: Maximum Toxicity Dose（MTD）","The MTD is based on the incidence of DLTs",{"measure":21,"description":22,"timeFrame":16},"Phase I: Recommended Phase II dose (RP2D)","The RP2D is based on the results of safety、PK\u002FPD and preliminary efficacy of SGT003 in the stage of dose escalation",{"measure":24,"description":25,"timeFrame":26},"Phase IIa: Objective Response Rate (ORR)","The ratio of CR and PR Evaluated by RECIST1.1 and iRECIST,","from date of randomization, until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, death, loss to follow-up, or study termination, whichever occurs first. average Up to 24 months",[28,32,35,38],{"measure":29,"description":30,"timeFrame":31},"Area under the plasma concentration-time curve (AUC)","area under the plasma concentration-time curve","From first study treatment to EOT, average of 24 months",{"measure":33,"description":34,"timeFrame":31},"Peak concentration (Cmax)","peak concentration",{"measure":36,"description":37,"timeFrame":31},"Time to peak concentration(Tmax)","time to peak concentration",{"measure":39,"description":40,"timeFrame":41},"Immunogenicity","ADA detection rate, ADA incidence rate, Nab detection rate (if applicable), Nab incidence rate (if applicable)","Starting from the first administration of investigational product until 28 days (+3 days) after EOT.",[43,47,49,52,56,59],{"measure":44,"description":45,"timeFrame":46},"Phase I. Objective Response Rate (ORR)","Evaluated by RECIST1.1 and iRECIST, from date of randomization, until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, death, loss to follow-up, or study termination, whichever occurs first.","average Up to 24 months",{"measure":48,"description":45,"timeFrame":46},"Phase I and phase IIa. Duration of Response (DOR)",{"measure":50,"description":51,"timeFrame":46},"Phase I and phase IIa. Disease Control Rate (DCR)","The ratio of CR、PR and SD Evaluated by RECIST1.1 and iRECIST, whichever occurs first.",{"measure":53,"description":54,"timeFrame":55},"Phase I and phase IIa. Time to Response (TTR)","The period from the date of randomization to the occurrence of CR\u002FPR，evaluated by RECIST1.1 and iRECIST, , until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, death, loss to follow-up, or study termination, whichever occurs first.","average up to 24 months",{"measure":57,"description":58,"timeFrame":46},"Phase I and phase IIa. Progression-Free Survival (PFS)","from date of randomization, until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, death, loss to follow-up, or study termination, whichever occurs first. Evaluated by RECIST1.1 and iRECIST,",{"measure":60,"description":61,"timeFrame":55},"Phase IIa. Overall Survival (OS)","the period from date of randomization to death",{"allocation":63,"interventionModel":64,"interventionModelDescription":65,"primaryPurpose":66,"observationalModel":65,"timePerspective":65,"maskingInfo":67},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":68,"maskingDescription":65,"whoMasked":65},"NONE","This is a first-in-human Phase I\u002FIIa clinical study evaluating the safety, tolerability, pharmacokinetic (PK) characteristics, immunogenicity, and preliminary efficacy of SGT003 in patients with advanced solid tumors. The study comprises a Phase I (dose-escalation) stage and a Phase IIa (dose-expansion) stage.",[71],{"label":72,"type":73,"description":74,"interventionNames":75},"SGT003","EXPERIMENTAL","Use SGT003 for Injection",[76],"Drug: SGT003",[78],{"type":79,"name":72,"description":80,"armGroupLabels":81,"otherNames":65},"DRUG","Dosage Form: Injection\n\nStrength: 50 mg (5 mL) per vial\n\nDosage and Administration: Subjects will receive SGT003 (investigational product) via intravenous (IV) infusion on Day 1 (D1) of each cycle. Dose: During the Phase I dose-escalation, subjects will be dosed according to the assigned dose cohort; during the Phase IIa dose-expansion stage, subjects will be dosed according to the selected expansion dose.\n\nDuration of Administration: For each subject, the first infusion will be completed within 90 minutes. If no infusion-related reaction (IRR) and\u002For hypersensitivity reaction occurs, the subsequent infusion duration may be shortened to no less than 60 minutes.",[72],[83],{"name":84,"role":85,"phone":86,"phoneExt":65,"email":87},"Shuchang Jiang","CONTACT","+86 13552250017","shuchang.jiang@hotgen.com.cn",[89],{"facility":90,"status":91,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":65},"Beijing Cancer Hospital","RECRUITING","Beijing","Beijing Municipality","100142","China","CN",{"type":98,"coordinates":99},"Point",[100,101],116.39723,39.9075,{"lat":101,"lon":100},{"type":104,"investigatorFullName":65,"investigatorTitle":65,"investigatorAffiliation":65,"oldNameTitle":65,"oldOrganization":65},"SPONSOR","100655202","phase-1-a-phase-iiia-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetic-characteristics-immunogenicity-and-preliminary-efficacy-of-sgt003-in-patients-with-advanced-solid-tumors-100655202",false,"NCT07811037","A Phase I\u002FIIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Efficacy of SGT003 in Patients With Advanced Solid Tumors","A Multicenter, Dose-Escalation and Expansion Phase I\u002FIIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Efficacy of SGT003 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Patient can fully understand the trial, participates voluntarily, and signs informed consent form (ICF) prior to any study procedures\n2. Patients aged 18 to 75 years at the time of ICF signature.\n3. Study population:\n\n   * Phase I (dose-escalation study): Patients with advanced solid tumors confirmed histologically or cytologically, who have failed at least one standard therapy for advanced disease, are intolerant to standard therapy, or have no available standard treatment options.\n   * Phase IIa (dose-expansion study): Patients with advanced solid tumors who have received at least first-line but not up to third-line standard systemic therapy and experienced disease progression or intolerance to such therapy.\n4. ECOG 0 or 1.\n5. Radiographic evidence (CT\u002FMRI, etc.) of disease progression documented during or after the most recent prior treatment.\n6. Patients must have adequate bone marrow reserve and organ function.\n\nExclusion Criteria:\n\n1. Subjects who have received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunosuppressive therapy or other anti-tumor therapy within 4 weeks prior to the first administration of the investigational product.\n2. Subjects who have received systemic immunosuppressant therapy within 14 days prior to the first administration of the investigational product.\n3. Subjects receiving anticoagulants such as therapeutic-dose heparin or vitamin K antagonists.\n4. Subjects who have received any live or attenuated live vaccine within 28 days prior to the first administration of the investigational product.\n5. Subjects who have undergone major surgery within 4 weeks prior to the first administration of the investigational product.\n6. Subjects with a history of Grade ≥3 immune-related adverse events (irAEs), hypersensitivity reactions, or Grade ≥2 immune-related myocarditis.\n7. Subjects with active autoimmune disease or prior autoimmune disease with a risk of recurrence. Exceptions: well-controlled type 1 diabetes, hypothyroidism controlled solely by hormone replacement therapy, and skin diseases that do not require systemic treatment.\n8. Subjects with current or prior active interstitial lung disease (ILD). Subjects with radiation-induced pulmonary fibrosis that does not require steroid therapy are eligible.","ALL","18 Years","75 Years",{"count":116,"type":117},332,"ESTIMATED","INTERVENTIONAL",[120,121],"PHASE1","PHASE2","A Phase I\u002FIIa clinical study SGT003 in patients with advanced solid tumors.",[124],"Advanced Solid Tumor",[72],"2026-09-06",{"date":128,"type":129},"2026-09-09","ACTUAL",{"date":131,"type":129},"2026-08-17",{"date":133,"type":117},"2029-06",{"name":5,"class":6},1]